Methods and devices for utilizing bondable materials

ABSTRACT

The invention primarily relates to fastening and stabilizing tissues, implants, and/or bondable materials, such as the fastening of a tissue and/or implant to a bondable material, the fastening of an implant to tissue, and/or the fastening of an implant to another implant. This may involve using an energy source to bond and/or mechanically to stabilize a tissue, an implant, a bondable material, and/or other biocompatible material. The invention may also relate to the use of an energy source to remove and/or install an implant and/or bondable material or to facilitate solidification and/or polymerization of bondable material.

CROSS REFERENCE TO RELATED APPLICATIONS

This non-provisional application is based upon and herein claimspriority to U.S. Provisional No. 61/155,133 filed Feb. 24, 2009. Thisapplication is related to U.S. patent application Ser. No. 12/202,210filed Aug. 28, 2008, U.S. patent application Ser. No. 11/689,670 filedMar. 22, 2007, U.S. patent application Ser. No. 11/671,556 filed Feb. 6,2007, and U.S. patent application Ser. No. 11/416,618 filed May 3, 2006,the entire contents of each are hereby expressly incorporated byreference into this disclosure as if set forth fully herein.

FIELD OF THE INVENTION

The invention relates to the fastening and stabilizing of tissues,implants, and bondable materials, such as the fastening of a tissueand/or implant to a bondable material, the fastening of an implant totissue, and/or the fastening of an implant to another implant. This mayinvolve using an energy source to bond and/or mechanically stabilize atissue, an implant, a bondable material, and/or other biocompatiblematerial. The present invention also relates to the use of an energysource to remove and/or install an implant and/or bondable material orto facilitate solidification and/or polymerization of bondable material.

BACKGROUND OF THE INVENTION

Body tissue often requires repair and stabilization to address weak orfractured bone, torn ligament or tendon, ripped muscle, or separation ofsoft tissue from bone. There are numerous methods to facilitate thisrepair and stabilization. For example, weak or fractured bones can bereinforced with bondable material, i.e. bone cement. Over time, thesebondable materials may loosen due to tissue deterioration, improperinstallation of bondable materials, or deterioration of the bondablematerials over time. Conventional procedures require removal of thebondable material, which is time consuming and potentially damaging tothe tissue. After the bondable material is sufficiently removed usingconventional methods, bondable material is reapplied to the tissue.Therefore, previous stabilization methods provided for the reapplicationof bondable materials and did not utilize existing bondable materials.There is a need for an improved method to utilize existing bondablematerials to stabilize tissue and implants.

In another example, bondable materials are used for the installation ofimplants, i.e. example bone cement. However, some implants loosestability over time. Previous stabilization methods require removal ofthe implant and the remaining bondable material left on the bone. Afterthe bondable materials are removed, new bondable material is applied tothe implant and/or bone. Again, this is a time consuming process,potentially damaging the surrounding tissue during the removal of theimplant and remaining bondable material.

Bone plates may be positioned internal to the skin, i.e. positionedagainst the fractured bone, or may be positioned external to the skinwith rods connecting the bone and plate. Conventional bone plates areparticularly well-suited to promote healing of the fracture bycompressing the fracture ends together and drawing the bone into closeapposition with other fragments and the bone plate. However, onedrawback with plates and screws is that with the dynamic loading placedon the plate, loosening of the screws, and loss of stored compressioncan result. There is a need for additional fixation devices and methodsrelated to bone plates and other implants providing support to bone.

In addition to internal or external bone plates, surgeons sometimes useintramedullary rods to repair long bone fractures, such as fractures ofthe femur, radius, ulna, humerus, fibula, and tibia. The rod or nail isinserted into the medullary canal of the bone and affixed therein byscrews or bolts. After complete healing of the bone at the fracturesite, the rod may be removed through a hole drilled in the end of thebone. One problem associated with the use of today's intramedullary rodsis that it is often difficult to treat fractures at the end of the longbone. Fastener members, such as bolts, are positioned through thecortical bone and into threaded openings in the rod. However, the numberand positioning of the bolt/screw openings are limited at the tip of therod because of the decreased surface area of the rod and the reducedstrength at the tip of the rod. Fractured bone sections at the distalend of a femur, for example, may not be properly fastened to usingconventional intramedullary rod stabilization techniques. Therefore,additional fixation devices and methods are required for use withintramedullary rods.

Other common methods to address weak or fractured bones use acombination of bone screws, bone plates, and intramedullary rods.Conventional methods of using bone screws required a sufficient depthwithin the bone to stabilize a bone plate. However, weak or fracturebones have limited purchase, as portions of the bone may be unfit forthe use of bone screws. Furthermore, if a intramedullary rod has beenused to stabilize the bone, the fixation area is further limited assurgeons generally avoid tapping into areas of bone with an underlyingintramedullary rod. An improved method of stabilizing existing boneplates and intramedullary rods is needed.

Existing systems and techniques for repairing tissue, like the onespreviously described, can be complex, time consuming, lack thecharacteristic of being employed with precision, be damaging to tissue,and/or fail to provide a robust fastening of tissue. Therefore, there isa need for an apparatus and method for the fastening of tissue thatinvolves a reduction in completion time, greater strength and precision,utilization of previously implanted materials, and preservation ofliving tissue. There is a need for a system that utilizes of previouslyinstalled fixation devices and techniques.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention, and theattendant advantages and features thereof, will be more readilyunderstood by reference to the following detailed description whenconsidered in conjunction with the accompanying drawings wherein:

FIG. 1 is a perspective view of an exemplary vibratory energy device;

FIG. 2 illustrates an embedding implant and end effector of theinvention;

FIG. 3 illustrates an alternative view of FIG. 2;

FIG. 4 illustrates an embedding implant connected to an end effector andembedded in a bondable material;

FIG. 5 illustrates an alternative welding horn or embedding implant ofthe invention;

FIG. 6 illustrates an alternative configuration of the end effector ofFIG. 3;

FIG. 7 illustrates a cross section through the center of a long axis ofthe end effector of FIG. 6;

FIG. 8 illustrates a cross section through the center of a long axis ofa fastening implant;

FIG. 9 illustrates an alternative view of FIG. 8;

FIG. 10 illustrates the embedding implant embedded in bondable materialand engaged with an fastening implant;

FIG. 11 illustrates an alternative configuration of the fasteningimplant of FIG. 9;

FIG. 12 illustrates a cross section through the center of a long axis ofthe fastening implant of FIG. 11;

FIG. 13 illustrates a washer for use with implants of the invention;

FIG. 14 illustrates a cross section through the center of a long axis ofFIG. 13;

FIG. 15 illustrates embedding implant embedded in bondable material;

FIG. 16 illustrates the fastening implant of FIG. 11 disposed in thewasher of FIG. 13 and engaged with the embedding implant of FIG. 15;

FIG. 17 illustrates the fastener of FIG. 11 bonded and/or staked to thewasher of FIG. 13;

FIG. 18 illustrates alternative configurations of implant of theinvention;

FIG. 19 illustrates alternative configurations of FIG. 18;

FIG. 20 illustrates an alternative configuration of an embeddingimplant;

FIG. 21 illustrates a cross section through the center of a long axis ofFIG. 20;

FIG. 22 illustrates an alternative configuration of the embeddingimplant of FIG. 2;

FIG. 23 illustrates a cross section through the center of a long axis ofFIG. 22;

FIG. 24 illustrates an alternative configuration of the embeddingimplant of FIG. 2;

FIG. 25 illustrates a cross section through the center of a long axis ofFIG. 24;

FIG. 26 illustrates the use of a fastening implant and an embeddingimplant to secure a supporting implant;

FIG. 27 illustrates the assembled configuration of FIG. 26;

FIG. 28 illustrates devices and methods related to utilization ofimplants and bondable materials;

FIG. 29 illustrates alternatives for the devices and methods of FIG. 28;

FIG. 30 illustrates alternatives for the devices and methods of FIG. 29and illustrates a method of connecting an instrument to an implant;

FIG. 31 illustrates an alternative method of connecting an instrument toan implant;

FIG. 32 illustrates the affixing an attachment to an implant;

FIG. 33 illustrates the use of a reservoir.

FIG. 34 illustrates an alternative configuration of FIG. 33.

FIG. 35 illustrates alternative types of reservoirs in an alternativetype of implant.

FIG. 36 illustrates an additional alternative type of implant.

FIG. 37 illustrates fixation to previously implanted bondable material.

FIG. 38 illustrates an alternative view of FIG. 37.

FIG. 39 illustrates an alternative configuration of the instrument ofFIG. 1.

FIG. 40 illustrates an exploded view of the instrument of FIG. 39.

FIG. 41 illustrates a method of utilization for the instrument of FIG.39.

FIG. 42 illustrates an alternative configuration of a fastening implant.

FIG. 43 illustrates an alternative view of FIG. 42.

FIG. 44 illustrates an alternative configuration of an embeddingimplant.

FIG. 45 illustrates an alternative view of FIG. 44.

FIG. 46 illustrates an alternative configuration of a fastening implant.

FIG. 47 illustrates an alternative view of FIG. 46.

FIG. 48 illustrates an energy signal through an end effector andimplant.

FIG. 49 illustrates an alternative configuration of an energy signalthrough an end effector and implant.

FIG. 50 illustrates an exploded view of the fastening implant of FIG.41.

FIG. 51 illustrates the fastening implant of FIG. 50 after staking.

FIG. 52 illustrates an exploded view of an alternative type of fasteningimplant.

FIG. 53 illustrates an alternative view of FIG. 52.

FIG. 54 illustrates an alternative configuration of a fastening implant.

FIG. 55 illustrates the fastening implant of FIG. 54 bonded to anotherimplant.

FIG. 56 illustrates an alternative configuration of a fastening implantor embedding implant.

FIG. 57 illustrates an expandable configuration of a fastening implantand expanding implant.

FIG. 58 illustrates an alternative view of FIG. 57.

FIG. 59 illustrates an alternative configuration of an implant,interference implant, and fastening implant.

SUMMARY

As is described in further detail below, fasteners may be embeddedwithin solidified bondable material, for example a grouting agent suchas bone cement (PMMA) or other acrylic based material. In an embodimentin accordance with the invention, an embedding fastener may be connectedto an end effector of a vibratory energy generator. The embeddingfastener may be adapted to enter and engage the bondable material thathas been locally melted by vibratory energy, and to be securely retainedtherein once the bondable material has cooled and hardened.

The end effector may be provided in any of a variety of shapes, oneexample being an elongated rod or shaft, connectable to a hand piece ata proximal end, and operative to transmit vibratory energy at a distalend. The fastener may be adapted to connect to the distal end of the endeffector, for example by mechanical interlocking, threading, twist lockconfigurations, friction fitting, or adhesive attachment. The mechanicalconnection must be operative, however, to communicate the vibratoryenergy from the end effector to the fastener.

The fastener is adapted to be securely retained within the bondablematerial or adhesive, in one embodiment, by being provided with a shapedor contoured surface upon which the adhesive may grip once hardened. Aroughened or porous surface may be provided alone or in combination witha shaped surface to increase purchase in bondable material and/orfacilitate an interference fit.

The fastener may further be provided with a taper at a leading end whichfirst enters the adhesive. The taper improves performance, at least, bypromoting accurate tracking and movement of the fastener into theadhesive, piercing tissue, and facilitating initial melting byconcentrating vibratory energy over a smaller surface region.

In a further embodiment of the invention, the embedded bone cementfastener (also referred to as an embedding fastener or embeddingimplant) described above is provided with one or more radial gaps,chambers, or ports, extending from a central bore. A polymeric fasteneris inserted within the central bore, and vibratory energy is applied tothe polymeric fastener, whereby polymer at the interface between theembedded fastener and the polymeric fastener melts. When the polymermelts, and particularly as pressure is applied to the polymeric fastenerin the direction of insertion, polymer enters the ports, flowing in adirection away from the central bore. When vibratory energy isdiscontinued, the polymer solidifies, and the polymer fastener isthereafter secured within the embedding fastener.

The embodiments of the present invention may be utilized with limitlessfixation techniques and in conjunction with other fasteners andimplants. Furthermore, the embodiments herein may assist in theinstallation and removal of tissue and implants. Moreover, theembodiments of the present invention may assist in the delivery oftherapeutic agents and employ methods that facilitate tissue growth andrepair. In addition, the embodiments herein may be used to applyvibratory energy to remove and/or install an implant in bondablematerial or to facilitate solidification and/or polymerization of thebondable material.

DETAILED DESCRIPTION

The invention relates to the devices and methods for the utilization ofbondable materials and bondable materials, fixation and fastening oftissue to tissue, an implant to tissue, and an implant to an implantboth inside and outside the body. The invention additionally relates toremoving and anchoring implants to bondable materials and/or otherbiocompatible materials, anchoring implants using previously implantedand hardened bondable materials, and fixation using vibratory energy,mixing, solidifying, bonding, and/or mechanical interlocking ofmaterials. The present invention also relates to the use of an energysource to install and/or remove an implant or bondable material or tofacilitate the solidification and/or polymerization of a bondablematerial

The methods and devices disclosed herein may be used in conjunction withany medical procedure on the body. The stabilization, fastening, and/orrepair of tissue or an implant may be performed in connection with anymedical procedure related to a joint, bone, muscle, ligament, tendon,cartilage, capsule, organ, skin, nerve, vessel, or other body parts. Forexample, tissue may be stabilized during intervertebral disc surgery,kyphoplasty, knee surgery, hip surgery, organ transplant surgery,bariatric surgery, spinal surgery, a+nterior cruciate ligament (ACL)surgery, tendon-ligament surgery, rotator cuff surgery, capsule repairsurgery, fractured bone surgery, pelvic fracture surgery, avulsionfragment surgery, shoulder surgery, hernia repair surgery, and surgeryof an intrasubstance ligament tear, annulus fibrosis, fascia lata,flexor tendons, etc.

Also, an implant may be inserted within the body and fastened to tissuewith the present invention. Such implant insertion procedures include,but are not limited to, partial or total knee replacement surgery, hipreplacement surgery, shoulder replacement surgery, bone fasteningsurgery, etc. The implant may be an organ, partial organ grafts, tissuegraft material (autogenic, allogenic, xenogenic, or synthetic),collagen, a malleable implant like a sponge, mesh, bag/sac/pouch,collagen, or gelatin, or a rigid implant made of metal (porous ornonporous), polymer, composite, or ceramic. Collagen may be provide thebenefit of bolstering tissue growth. Additionally, a dessicated collogenmay be used to absorb surrounding fluid, which may provide theadditional benefit of applying pressure on the tissue being repaired.Other implants include breast implants, biodegradable plates, porcine orbovine patches, metallic fasteners, compliant bearing for medialcompartment of the knee, nucleus pulposus prosthetic, stent, suture,suture anchor, tissue graft, tissue scaffold, biodegradable collagenscaffold, and polymeric or other biocompatible scaffold. The scaffoldmay include fetal cells, stem cells, embryonic cells, enzymes, andproteins.

In this application, the term “bondable” or “bondable material” is usedto refer to the materials discussed herein, as well as any material,suitable for in vivo applications, which can be softened and madeflowable by the application of heat (such as heat produced withvibratory energy such as ultrasonic energy), and which, when softened,may become tacky and will bond to other materials and will flow to fillavailable space. Thus, the material may be thermoplastic, but it mayalso exhibit tackiness or bonding ability when in its plastic form. Manymaterials suitable for in vivo applications are made of or incorporatesuch bondable materials. Generally speaking, the amount of heat neededto soften and make flowable should be within a temperature range thatdoes not produce substantial thermal tissue necrosis. Alternativelystated, the amount of heat required to soften the bondable materialduring vibratory bonding is substantially confinable, due to the thermalproperties of the bondable material, to an area of contact between theobjects which are being bonded, thereby protecting living body tissuenear the contact between the two objects from substantial thermal tissuenecrosis. Any embodiment herein may be used with any of the materialsand/or applications disclosed herein or known in the art.

The fixation and fastening system and other embodiments of the presentinvention contemplates the use any materials that may include or be usedin conjunction with bondable materials for bonding and/or staking withinthe human body. Implants that may be used as fasteners may also bereferred to as fastening implants. Bondable material used may include,but are not limited to, biocompatible, degradable, biodegradable,bioerodible, bioabsorbable, mechanically expandable, hydrophilic,bendable, deformable, malleable, riveting, threaded, toggling, barded,bubbled, laminated, coated, blocking, pneumatic, one-piece,multi-component, solid, hollow, polygon-shaped, pointed,self-introducing, and combinations thereof. Also, the devices mayinclude, but are not limited to, metallic material, polymeric material,ceramic material, composite material, body tissue, synthetic tissue,hydrophilic material, expandable material, compressible material,bondable material, and combinations thereof. Bondable material may alsoinclude polymethyl methacrylate (known as “PMMA” or “bone cement”),glue, adhesive, and/or other grouting agents or acrylic materials usedfor fixation.

In this application, “bond”, “bonded”, and “bonding” includes, but isnot limited to, attaching, engaging, connecting, binding, adhering,and/or fastening one or more materials through resistive heating,mechanical interlocking, application of force, application of groutingagents (i.e. bone cement), adhesives and/or solvents, spraying,radiofrequency, vibratory energy (i.e. ultrasound), microwave, laser,electromagnetic, electro shockwave therapy, plasma energy (hot or cold),and other suitable method described herein or known in the art.

Preferably, materials of the present invention can melt with theapplication of energy, becoming gel-like, tacky, and/or soft. The energysource and the technique used to bond and/or stake the material withinthe body can be selected to minimize or avoid damage to surrounding bodytissue. Exemplary materials that may be used may include polymers,ceramics, composites, and metals, although other materials may also besuitable for use with the invention. While the present inventioncontemplates the use of any of these materials in any of the followingembodiments, polymeric material is used in the following examples anddescription simply to illustrate how the invention may be used.

There are a limitless number of materials may be used for the presentinvention. Examples of amorphous polymers are polycarbonate (LEXAN),polystyrene, polysulfone (ULDALL), and acrylics polycarbonate (ABS andstyrenes). Examples of semi-crystalline polymers include acetyl(DELRIN), nylon, polyester, polyethylene, polyether ether ketone,polypropylene, polyvinylchloride (PVC), and Caprolactam. Biodegradablesemi-crystalline polymers may include polylactic acid and polyglycolicacid. Copolymers of PGA and PLA may also be used. Poly-l-lactide (PLLA)or other forms of PLA may also be used. Other polymers which may be usedwith the present invention, either as a thermoplastic ornon-thermoplastic, are polyethylene glycol (PEG)-copolymers andD,L-lactide-co-glycolide polyesters. Some semi-crystalline materials areparticularly suitable for surgical bonding and/or staking, especiallyvibratory bonding and staking. Examples of such materials include PAEK(polyaryletherketone), including PEEK (polyetheretherketone) and PEKK(polyetherketoneketone).

In addition to PEEK and the other polymers described herein, theimplants, devices, and methods of the present invention may use keratin,a naturally occurring polymer. Keratin may be vibratory bonded or stakedto itself, to other implants, or within tissue. This may be performed inthe operating room or intracorporeally. Keratin may be bonded tocollagen or to other known polymers. In an exemplary application,keratin may be used to fasten tissue to bone since keratin has BMP andtissue scaffold properties. It is contemplated that any of devices andmethods disclosed herein may utilize keratin alone or in combinationwith PEEK, polylactic acid, or other polymer. Keratin may be used tomake fasteners, disc replacements, joint replacement components, stents,cell scaffolds, drug reservoirs, etc. Also, joint bearing surfaces mayinclude keratin with or without collagen or chondrocytes. The bearingsurfaces may be fastened to a joint component using PEEK or PLAfasteners.

Another polymer that can be used with the present invention is a classof natural materials, called polyhydroxyalkanoates, or PHA polymers.These polymers are synthesized in nature by numerous microorganisms, andthey have been recently recognized as the fifth class of naturallyoccurring biopolymers (along with the polyamino acids, polynucleicacids, polysaccharides, and polyisoprenoids). Unlike the other naturallyoccurring biological polymers, however, the PHA polymers arethermoplastic, i.e. they may be repeatedly softened with heat andhardened with cooling. As such, these polymers can be processed muchlike other plastics. A specific example of a PHA polymer that could beused is poly-4-hydroxybutyrate material. Such PHA polymers are availablefrom Tepha Inc of Lexington, Mass.

Fasteners of the invention may utilize or be coated withpolymethylmethacrylate (PMMA), in order to promote bonding with PMMAused in the body, or PMMA could be incorporated into polymer of thefastener, or deposited within cavities or shapes formed in the fastenersurface, including threaded, roughened, porous, or nano textures. Afastener may be thus coated with PMMA, or formed entirely of PMMA, andmay be heat bonded, advantageously using ultrasound, to another PMMAsurface or other adhesive surface, otherwise as described herein withrespect to bone cement. Although PMMA, known generally as bone cement,and other polymers may function more as a grouting agent than a cementor adhesive. The term “bondable material” is used throughout thespecification for simplicity.

In accordance with the invention, metals are advantageously connectedwith fasteners incorporating polymeric materials. Any of a variety ofmetals may be used, either smooth or formed with at least portionsformed of metal, or a roughened or porous surface, or formed withcavities or other shapes upon which polymeric material may mold, enter,adhere, or otherwise affix. The polymer is softened in accordance withthe invention through the application of heat, including heat createdusing vibratory energy, to become tacky, or sufficiently softened inorder to bond on a microscopic level, or a macroscopic level throughadaptation to the surface structure of the metal. For use in vivo,biocompatible metals are used, including stainless steel, nitinol orother SMA (shape metal alloy), tantalum, porous tantalum, titanium,cobalt-chrome alloys, and other metals such as are known to thoseskilled in the art. Additional related information, including bondingpolymers and metals, and polymer to polymer bonding of implantmaterials, may be found in U.S. Pat. Nos. 5,163,960 entitled “Surgicaldevices assembled using bondable materials”, and 7,104,996 entitled“Method of performing surgery”, the contents of each of which beingincorporated herein by reference.

The fastening device of the present invention may include therapeuticsubstances to promote healing. These substances could includeantibiotics, hydroxypatite, anti-inflammatory agents, steroids,antibiotics, analgesic agents, chemotherapeutic agents, bonemorphogenetic protein (BMP), demineralized bone matrix, collagen, growthfactors, autogenetic bone marrow, progenitor cells, calcium sulfate,immo suppressants, fibrin, osteoinductive materials, apatitecompositions, germicides, fetal cells, stem cells, enzymes, proteins,hormones, cell therapy substances, gene therapy substances, andcombinations thereof. These therapeutic substances may be combined withthe materials used to make the device. Alternatively, the therapeuticsubstances may be impregnated or coated on the device. Time-releasedtherapeutic substances and drugs may also be incorporated into or coatedon the surface of the device. The therapeutic substances may also beplaced in a bioabsorbable, degradable, or biodegradable polymer layer orlayers.

The therapeutic agents may also be placed within one or more cavitiesdisposed in a fastening device of the present invention. Differentagents may be disposed in different cavities of the device tospecifically tailor the implant for a particular patient. Dosages of thetherapeutic agent may be the same or different within each of cavitiesas well. The cavities may include a cover which may release the agent ina controlled or timed manner. The cover may be biodegradable orbioerodible to allow the agent to release to surrounding tissue.Examples of suitable therapeutic agents include bone growth inducingmaterial, bone morphogenic proteins, osteoinductive materials, apatitecompositions with collagen, demineralized bone powder, or any agentpreviously listed. U.S. patent application Ser. No. 11/549,994 entitled“Drug Eluting Implant” discloses means for delivering therapeuticagents. The above-mentioned patent application is incorporated byreference herein in its entirety.

The fastening devices of this and other embodiments of the invention maybe used in combination with fasteners in the prior art. Examples offasteners, implants, and their methods of employment may be found inU.S. Pat. Nos. 5,163,960; 5,403,348; 5,441,538; 5,464,426; 5,549,630;5,593,425; 5,713,921; 5,718,717; 5,782,862; 5,814,072; 5,814,073;5,845,645; 5,921,986; 5,948,002; 6,010,525; 6,045,551; 6,086,593;6,099,531; 6,159,234; 6,368,343; 6,447,516; 6,475,230; 6,592,609;6,635,073; and 6,719,765. Other fastener types are disclosed in U.S.patent application Ser. Nos. 12/202,210; 10/102,413; 10/228,855;10/779,978; 10/780,444; and 10/797,685. The above cited patents andpatent applications are hereby incorporated by reference in theirentirety.

With reference to FIG. 1, any known energy emitting instrument may beused with the surgical system of the present invention. Instrument 100may produce energy such as resistive heating, radiofrequency, ultrasound(vibratory), microwave, laser, electromagnetic, electro shockwavetherapy, plasma energy (hot or cold), and other suitable energydisclosed herein or known in the art. FIG. 1 illustrates an exemplaryhandpiece or instrument 100 that may be used with the present invention.The instrument 100 may be a vibratory energy generator with a sheath 102to cover and protect the end effector 104 and engage a fastener/implantnear engagement feature 106. As will be discussed below, the instrumentmay be used to bond and/or mechanically interlock fasteners and otherembodiments the present invention. Additional embodiments of instrument100 are disclosed in U.S. patent application Ser. No. 12/202,210entitled “Methods and Devices for Utilizing Thermal Energy to Bond,Stake and/or Remove Implants”, which is incorporated by referenceherein.

With reference to FIGS. 2-7, end effector 104 may be utilized withanchor or embedding fastener 110. Embedding fastener 110 may also bereferred to as an embedding implant. FIG. 2 illustrates end effector 104that connects to embedding fastener 110 with distal end 108. Theconnection between distal end 108 and embedding fastener 110 may utilizethreads, magnetism, friction, taper, ball and socket, linkage, adhesive,interlocking shapes, and other connections known in the art.Additionally, distal end 108 and embedding fastener 110 may bepermanently or detachably connected.

As shown in FIG. 2, embedding fastener 110 may further be provided witha taper 114, which first enters bondable material 120 in FIG. 4. Taper114 may improve performance, for example, by promoting accurate trackingand movement of embedding fastener 110 into bondable material 120,piercing body tissue, and facilitating initial melting by concentratingvibratory energy over a smaller surface region. Although embeddingfastener 110 may be made of any material described herein or known inthe art, it may be preferable to use titanium.

As discussed in further detail below, embedding fastener 110 may alsohave feature 112 and/or feature 116, either or both may be a surfacefeature, recess, or pass through a portion or the entirety of embeddingfastener 110.

Referring to FIG. 3, an embodiment of end effector 104 may have proximalend 118 to the other components of instrument 100. The connectionbetween instrument 100 and proximal end 118 may be threaded, magnetic,friction, hex, ball and socket, linkage, adhesive, and other methodsdisclosed herein or known in the art.

As shown in FIGS. 3-7, end effector 104 may be provided in any of avariety of shapes, one example being an elongated rod or shaft,connectable to a hand piece at a proximal end 118, and operative totransmit vibratory energy at a distal end 108. While a rod shape isshown and selected for reduced manufacturing cost, end effector 104 mayhave the form of box or hex channel, oval or other shape, provided itcommunicates vibratory energy to a distal end 108, an attached fastener,or embedding fastener 110. Additionally, feature 111 of FIG. 5 may beused on embedding fastener 110 or integrated into end effector 104 (notshown).

In an additional embodiment, embedding fastener 110 is adapted toconnect to distal end 108 of end effector 104 by mechanicalinterlocking, as by a bore in embedding fastener 110, sized to receivedistal end 108 of end effector 104, optionally provided with internal orexternal threading (not shown), wherein post 108 has mating threads.Additionally, the connection may be threaded, magnetic, friction, hex,ball and socket, linkage, adhesive, and other methods disclosed hereinor known in the art. Similarly, a bore or aperture may be provided inend effector 104, mateable with a post or projection on embeddingfastener 110. Other mechanical connections are contemplated, includingtwist lock configurations, friction fitting, or adhesive attachment. Themechanical connection should preferably be operative to communicatevibratory energy from end effector 104 to embedding fastener 110, as bya firm mechanical connection.

As shown in an embodiment of FIG. 4, embedding fastener 110 may beadapted to be securely retained within bondable material 120 by beingprovided with a shaped or contoured surface upon which the softenedbondable may adhere. A roughened or porous surface may be provided aloneor in combination with shaped surface thereby providing for increasedpurchase in bondable material 120.

With reference to FIG. 4, embedding fastener 110 may be embedded withinsolidified bone bondable material 120, for example PMMA, acrylic basedadhesive, or other bondable materials. In the present invention,embedding fastener 110 is connected to end effector 104 of an embodimentof instrument 100, such as a vibratory energy generator as shown inFIG. 1. Embedding fastener 110 is adapted to enter and engage bondablematerial 120 or bondable material 120 that has been locally melted byvibratory energy (as shown in FIG. 4), through contact between embeddingfastener 110 and bondable material 120 during operation of instrument100. Embedding fastener 110 is securely retained by bondable material120 once the latter has hardened. Although the embodiment in FIG. 4 maybe used under a limitless number of configurations and settings, Table 1is being set forth with operative examples:

TABLE 1 Titanium Embedding Fastener Bonded into PMMA Force DeformationTest Sample Power Applied to Depth Number (watts) Time (sec) Break(lbs.) (inches) 1 63 2.56 46.7 0.116 2 48 2.01 61.9 0.119 3 48 1.58 32.50.109 4 48 1.47 31.5 0.098 Embedding Fastener Type: Shown in FIG. 20Instrument: Handpiece SN0105 with tuning of 39,000-45,000 Hz SystemSettings: Sample 1: 40,850 Hz, 100 W, 2.0 sec weld time Sample 2: 40,750Hz, 75 W, 1.5 sec weld time Sample 3: 40,800 Hz, 75 W, 1.0 sec weld timeSample 4: 40,750 Hz, 75 W, 1.0 sec weld time

Once anchored, end effector 104 and embedding fastener 110, embedded inbondable material 120, may remain connected. Alternatively, end effector104 may be removed and another fastener of a similar or different designmay be connected to an implanted embedding fastener 110 as shown inFIGS. 8-10. In a further embodiment, fastener 124 such as described inthe incorporated patents and applications may be fastened to animplanted or installed embedding fastener 110. Fastener 124 may havefastener bore 128 as shown in FIGS. 8-9. Referring to FIG. 10, abondable insert 134 may be secured into fastener bore 128. Bondableinsert 134 may be secured by press fitting, threading, or bonding tofastener bore 128 and/or embedding fastener 110. The fastener 124 may beutilized as detailed in U.S. patent application Ser. No. 12/202,210,which has been incorporated by reference herein. In further embodiments,any fastener described in the related references cited in paragraph[0001] or discussed herein may be fastened to the embedding fastener110, then secured in its respective manner.

In an additional embodiment, embedding fastener 110 may be used toremove an implant and/or bondable material 120. For example, the abilityof conventional medical tools to remove a previously installed implantor bone cement may be limited. Embedding fastener 110 may be used toobtain additional fixation. Once embedding fastener 100 is secured tothe implant and/or bondable material 120, force and/or vibratory energymay be used to remove the implant and/or bondable material 120.

FIGS. 11-17 show an additional embodiment for use with an implantedembedding fastener 110. Fastener 136 is show in FIGS. 11-12 and washer146 is shown in FIGS. 13-14. Although fastener 136 and washer 146 may bemade of any material disclosed herein or known in the art, it may bepreferable to use PEEK. After embedding fastener 110 has been securedwith respect to bondable material 120, fastener 136 may be engaged intoembedding fastener 110. In another embodiment, washer 146 may be used inconjunction with fastener 136 as shown in FIGS. 15-17. Additionally,fastener 136 may be bonded to embedding fastener 110 and/or washer 146.

Referring to FIGS. 18-19, fastener 136, washer 146, and/or tissueimplant 154 may be used to secure soft tissue 152 to hard tissue 156,for example to secure the rotator cuff tissue to the proximal humerus orfor any other procedure disclosed herein. Additionally, washer 146and/or tissue implant 154 could be made of collagen or other materialsthat promote tissue growth.

With reference to FIGS. 20-25, embedding fastener 110 may be providedwith channel 112. For example, channel 112A, 112B, 112C, and/or 116 maybe used. Channel 112 may extend through the surface of embeddingfastener 110 to facilitate the bonding of embedding fastener 110 tobondable material 120, fastener 136, and/or any fastener disclosedherein. Channel 112 may provide a path for softened and/or moltenbondable material to be displaced, providing room for entry of embeddingfastener 110. Channel 116 may also include radial gaps, chambers, orports. To accommodate for embedding fastener 110 displacing asubstantial amount of material, channels may be extended along theentire length of embedding fastener 110, and may further extend alongend effector 104. Channel 116 may be further operative to reduce thepossibility of rotation of fastener 110 within bondable material 120.Channel 116 is thus disposed to extend into bondable material 120 afterinsertion, and may extend to the face of embedding fastener 110.Additionally, embedding fastener 110 may have feature 158 to help attachand remove it from end effector 104.

In an embodiment shown in FIGS. 26-27, implant 162 may be coated inbondable material 164 and implanted in body tissue 160. For example, ametal rod coated with bone cement may be placed in the intramedullarycanal of a bone. In an embodiment, support 168 may placed in a locationto facilitate stabilization. Support 168 and/or washer 146 may bereferred to as a supporting implant. One or more holes may be formed inbody tissue 160 and up to or into bondable material 164 to coincide withthe holes in support 168. Embedding fastener 110 may be placed throughthe holes in body tissue 160 and secured to and/or bonded to bondablematerial 164 as discussed herein. Then, one or more of fastener 136 aresecured to and/or bonded to the one or more embedding fastener 110,thereby securing support 168 relative to body tissue 160.

Referring to FIG. 28, implant 162 may be installed in a body tissue 160with bondable material 164, for example bone cement. Bondable material164 may be any material described herein or known in the art. Implant162 may require stabilization because implant 162 has become looseand/or requires stabilization due to tissue defect 166, for example aperiprosthetic fracture. Tissue defect 166 may include, but is notlimited to, damaged, deformed, and/or diseased bone, muscle, ligament,tendon, cartilage, capsule, organ, skin, nerve, vessel, or other bodypart. For example, a femur may be fractured or contain osteoporosis.Support 168 is fixed to body tissue 160 with fastener 170 to providestabilization. Support 168 may be an internal bone plate, an externalbone plate, a spinal plate, a wedge, a cushion, a pad, or otherbiocompatible support used for stabilization of tissue and/or implants.Fastener 170 may be any fastener described herein or any otherbiocompatible fastener known in the art.

In an embodiment, implant 162 has been previously installed and requiresstabilization. One or more holes are formed through body tissue 160 andup to or into bondable material 164. Embedding fastener 110 is insertedthrough a hole and bonded to bondable material 164 by utilizinginstrument 100 described above. Fastener 170 engages embedding fastener110 to secure support 168 to body tissue 160. The head of fastener 170may be deformed and/or bonded to support 168 to reduce loosening offastener 170.

Embedding fastener 110 can also be bonded to bondable material 164C/Dthat is within or on the surface of body tissue 160. For example,bondable material may have been used to repair tissue defect 166.Bondable material 164 may be within or on the surface of body tissue160. A hole is formed up to or into the bondable material 164. Embeddingfastener 110 is bonded into bondable material 164. Fastener 170 passesthrough support 168 and into engagement with embedding fastener 110 tosecure support 168 relative to body tissue 160.

In another embodiment, embedding fastener 110A/B can be bonded to and/orinto implant 162. The procedure is performed as described above, exceptthe embedding fastener 110 may be bonded directly to implant 162.

In another embodiment, bondable material 164 may asymmetrically coverall or a portion of implant 162. The thickness of bondable material 164could vary in the radial direction or along the length of implant 162.An asymmetrically coated implant 162 may provide additional purchase forfastener 136 or indication of orientation or position of implant 162.

In an additional embodiment, indirect visualization may be used toidentify and/or change the orientation or position of implant 162 orfastener 136. Examples of indirect visualization may include endoscopicguidance, computer assisted navigation, magnetic resonance imaging(MRI), CT scan, ultrasound, fluoroscopy, X-ray, or other visualizationtechnique disclosed in any of the references incorporated herein.Asymmetric coating, radiopaque markers, or other features identifiablewith indirect visualization may be used to identify and/or adjustorientation or position. Indirect visualization may also be used toalign fastener 136 with holes in implant 162 or bondable material 164.The holes may be predrilled in implant 162 or bondable material 164 ormay be drilled after installation of 162. Indirect visualization may beused to create a hole or holes in tissue to align with holes in implant162 or bondable material 164.

For example, an intramedullary rod could be asymmetrically coated withPEEK. The intramedullary rod could have predrilled holes in the PEEKcoating. After the rod is installed in the intramedullary canal of thetibia, the orientation of the rod may be determined using indirectvisualization to locate the area with a thicker coating. The orientationof the rod may be adjusted to the appropriate location for holes to bemade through the tissue.

With further reference to FIG. 28-29, various types of fastening devicesare used to position support 168 along body tissue 160. Alternatively,support 168 may be positioned upon the surface of the skin, or at anypoint between the tissue surface and the skin, according to therequirements of the surgical procedure. Further, support 168 may beplaced within the bone, for example in an intramedullary canal.

Referring to FIG. 29, fastener 170 may be used in intramedullary,percutaneous, and/or retrograde approaches. Fastener 170 may be bondedto bondable material 164, or a surface of implant 162. The head offastener 170 may be provided, or may be formed using vibratory energy. Ahead may also be formed on the distal end of fastener 170. Fasteners170E are shown to be bonded into the bondable material 164. Fastener170F is shown to be bonded at the distal end and/or to bondable material164 within the body tissue and is placed through tissue defect 166.Fasteners 170G are shown passing directly through body tissue 160, whichmay be fastener 170T and sleeve 171T in FIGS. 52-53 and as describedbelow. Additional embodiments of fastener 170 are disclosed in U.S.patent application Ser. No. 12/202,210 entitled “Methods and Devices forUtilizing Thermal Energy to Bond, Stake and/or Remove Implants”, whichis incorporated by reference herein.

Additionally, cerclage wire 172 may be employed as known in the art, toprovide further stabilization, in combination with fastener 170. Forexample, cerclage wire 172A may be bonded to support 168. Bondablematerial 164E could be used to affix cerclage wire 172A to support 168.In another example, cerclage wire 172B may be tied around support 168.Also, cerclage wire 172C may be fastened using a mechanical or bondedcrimp 174. In additional example, cerclage wire 172D may fastened to theside of support 168 or between support 168 and body tissue 160.

Referring to FIG. 30, end effector 104 of instrument 100 may beconnected into implant 162 at recess 180. This connection may bethreaded, magnetic, friction, hex, ball and socket, linkage, adhesive,and other connections suitable for transferring vibratory energy asdisclosed herein or known in the art. Also, other vibratory energydevices as disclosed herein or known in the art may be utilized.

FIG. 30 also shows additional methods of stabilizing a loose implantand/or facilitating the solidification and/or polymerization of bondablematerial 164. For example, fastener 170H may be a metal and/or polymerfastener, which may be affixed to the bondable material 164 and/orimplant 162 to stabilize implant 162. In another example, fastener 170Imay be metal coated with bondable material. Upon the application ofvibratory energy and/or heat, distal end 182A deforms therebystabilizing the gap between implant 162 and body tissue 160. In anadditional example, fastener 170J may be made of bondable material. Uponthe application of vibratory energy and/or heat, distal end 182Bdeforms, thereby stabilizing the gap between implant 162 and body tissue160.

Referring to FIG. 31, end effector 104 of instrument 100 may beconnected into implant 162 with coupler 184 to stabilize previouslyhardened and/or polymerized bondable material 164 or to facilitatesolidification and/or polymerization of bondable material 164. Thisconnection may be threaded, magnetic, friction, hex, ball and socket,linkage, adhesive, and other connections suitable for transferringvibratory energy as disclosed herein or known in the art. Also, othervibratory energy devices disclosed herein or known in the art may beutilized.

Referring to FIG. 32, attachment 186 may be attached and/or bonded toimplant 162. Attachment 186 may be made from any material describedherein (i.e. collagen, graft, or growth promoter) or any other materialknown in the art, preferably to promote healing and/or contain bondablematerial 164. For example, vibratory energy may be used to bondattachment 186 to implant 162. In another example, fastener 170 maysecure attachment 186 to implant 162. In an additional example,vibratory energy may be used to bond fastener 170 to attachment 186.

Referring to FIGS. 33-34, implant 162 may be manufactured with reservoir192 or reservoir 192 may be formed during or after implantation.Additionally, therapeutic substance 194 may be incorporated in reservoir192 of implant 162, impregnated in implant 162, or coated on or inimplant 162. As shown in FIG. 33, reservoir 192 may be located inimplant 162. Alternatively, reservoir 194 may be formed in body tissue160, as shown in FIG. 34. Cap 188 may be made of bondable material.Additionally, cap 188 may be attached and/or bonded to enclose reservoir192. Implant 162, cap 188, and/or body tissue 160 may contain attachmentfeature 190 and/or attachment recess 196 to facilitate mechanicalattachment and/or bonding with end effector 104. Additionally, implant162, cap 188, and/or bondable material 164 may be porous to facilitatethe delivery of therapeutic substance 194.

Referring to FIG. 35, therapeutic substance 194 may be contained inimplant 198, for example drugs or antibiotics contained in an acetabularcup. Implant 198 may be manufactured with reservoir 192A and/orreservoir 192B or the reservoirs may be formed during implantation. Anycombination of one or more reservoir 192A and/or reservoir 192 may beused. Cap 188 may be coated with bondable material. Additionally, any ofcaps 188A-D may be attached and/or bonded to enclose reservoir 192A or192B, which may provide the potential benefit of multiple release timesfor therapeutic substance 194 Caps 188A-D may contain attachmentfeatures 190A-D to facilitate mechanical attachment and/or bonding.Additionally, implant 198 and/or any of caps 188A-D may be porous tofacilitate the delivery of therapeutic substance 194.

Referring to FIG. 36, fastener 170 may be used to stabilize implant 162,for example a tibial component of a total knee arthroplasty (TKA). In anembodiment, fastener 170K may be bonded to bondable material 164 on theunderside of the implant or bonded directly to implant 164. In anotherembodiment, fastener 170L may be bonded to the portion of implant 162that is within body tissue 160. In an additional embodiment, fastener170 may be used to secure tissue graft 202 to implant 162 and/or bodytissue 160. For example, tissue graft 202 may be an allograft. Anyembodiment of fastener 170 that has been described herein or known inthe art may be used.

Referring to FIGS. 37-38, bondable material 164 may be utilized tostabilize body tissue 160. For example, bone cement in previouslyperformed kyphoplasty may become loose and require additionalstabilization. In this example, the fasteners may utilize the previouslyimplanted bone cement to stabilize the spine instead of removing andreapplying bone cement. In an embodiment, body tissue 160 has beenpreviously implanted with bondable material 164. Fastener 170N is passedthrough support 168 and bonded to bondable material 164. As shown inFIG. 37, one or more fastener 170 is passed through support 168 andsecured and/or bonded to surrounding tissue 200. Fasteners 170M, 170N,and 170P may be any embodiment disclosed herein or known in the art.Additionally, fasteners 170M, 170N, and 170P may be used with embeddingfastener 110 as described above. Also in these embodiments, vibratoryenergy may be used to stabilize previously hardened and/or polymerizedbondable material or to facilitate the solidification and/orpolymerization of bondable material.

Referring to FIGS. 39-41 and 50-51, an additional embodiment ofinstrument 100 includes guide sheath 102, spring 204, and/or forceregulator 206. In an embodiment in FIG. 41, guide sheath 102 may alignwasher 146 when the tip of end effector 104 is placed in contact withfastener 136. As fastener 138 is staked and the tip of fastener 136 isshaped with the application of vibratory energy, such as ultrasonicenergy, guide sheath 102 may allow end effector 104 to advance whileapplying force to washer 146, support 168, body tissue 160, and/orbondable material 164 (not shown in FIG. 41). In a further embodiment inFIG. 41, guide sheath 102 may hold, guide, align, and/or deliver washer146, fastener 136, or other fasteners referenced herein or known in theart. In an additional embodiment, regulating sheath 206 may have aspring 204, for example any spring, cushion, or other material or deviceknown in the art for spring/damping applications. Additionally,instrument 100 may have regulating tab 206 for manually applying and/orregulating the movement of guide sheath 102. Although the embodiment inFIG. 41 may be used under a limitless number of configurations andsettings, Table 2 is being set forth with operative examples:

TABLE 2 Polycarbonate Fastener Bonding Energy Force Deformation TestSample Power Application Applied to Depth Number (watts) Time (sec)Break (lbs.) (inches) 1 30 1.69 93.2 0.115 2 28 1.68 86.4 0.110 3 311.78 98.2 0.111 4 27 1.80 91.3 0.108 5 31 1.69 109.2 0.109 Instrument:Handpiece P05 with tuning of 39,000-45,000 Hz System Settings: 39,500Hz, 50 W, 1.0 sec weld time

In additional embodiments, frequency may preferably be between 20 to 80khz, power may preferably be between 5 to 200 watts, and energyapplication time may be preferably between from 0.1 to 5 seconds.

In an embodiment, a sensor may be included in instrument 100. Forexample, a force, pressure, or temperature sensor may be used to measurebonding and/or staking. In another example, a visual and/or audioindicator may be operatively connected to the sensor, which may be usedto indicate a proper bond/stake. In another embodiment, a visual and/oraudio indicator may be connected to instrument 100 or the energygenerator, which may be used to illustrate and/or teach proper techniqueduring bonding and/or surgery. In another example, the visual and/oraudio indicator may indicate completion of a proper bond/stake,over/under application of force, or expiration of desired energyapplication time.

In another embodiment, a vacuum may be operatively connected to 100. Forexample, the vacuum may be communicatively connected between the guidesheath 102 and end effector 104, which may be used for the removal ofdebris from instrument 100.

Referring to FIGS. 42-43, an additional embodiment of fastener 170 mayinclude one or more feature 208. Feature 208 may increase or decreasethe transfer of energy across fastener 170. Feature 208 may pass intothe surface or through fastener 170. Feature 208 may be on any surfaceor surfaces of fastener 170 and/or contain therapeutic substances.Fastener 170 may include effector interface 210, preferably forengagement with end effector 104.

Referring to FIGS. 44-45, embedding fastener 110 may also include thread212. Embedding fastener 110 may be screwed and/or engaged into bondablematerial, tissue, and/or any other material disclosed herein, preferablyby engaging interface 214 with a screw driver or other tool. Embeddingfastener 110 may include an interface 214 which may be radiused,chamfered, funnel-shaped, threaded, or any other shape, for examplesquare, rectangular, circular, elliptical, triangular, hexagonal, orasymmetrical shape. Embedding fastener 110 may be made of any metal,polymer, or other material disclosed herein.

Referring to FIGS. 46-47, fastener 170 may include effector interface216. Preferably for engagement with end effector 104, effector interface216 may be radiused, chamfered, funnel-shaped, threaded, or any othershape, for example square, rectangular, circular, elliptical,triangular, hexagonal, or asymmetrical shape.

Referring to FIGS. 48-49, instrument 100 may include end effector 104dimensioned and configured for a point of maximum displacement at ornear the middle of fastener 170 at or near point 218B (FIG. 49). Inanother embodiment, it may be preferable for instrument 100 to includeend effector 104 dimensioned and configured for a point of maximumdisplacement at or near the end of fastener 170 at or near point 218A(FIG. 48). For most applications, a point of maximum displacement at ornear point 218B is preferred. Fastener 170 may be threaded or have aninterference fit with end effector 104.

A point of maximum displacement along end effector 104 may occur atincrements of about half its wavelength, which may be determined by theratio of the speed of sound through the material of end effector 104 tothe frequency of the wave propagated through end effector 104. The endeffector 104 may be made of titanium or any material disclosed herein.For example, at a frequency of 20 khz, points of maximum displacementalong end effector 104 made of titanium may be in increments of about 4to 6 inches, preferably 4.8 to 5.1 inches. For example, at a frequencyof 40 khz, points of maximum displacement along end effector 104 made oftitanium may be in increments of about 2 to 3 inches, preferably 2.4 to2.5 inches

A point of maximum displacement along fastener 170 may also occur atincrements of about half its wavelength. Fastener 170 may be made ofPEEK, PLLA, or any material disclosed herein. As an example for PEEK, ata frequency of 20 khz, points of maximum displacement along end effector104 may be in increments of about 1 to 2 inches, preferably 1.6 to 1.7inches. As another example for PEEK, at a frequency of 40 khz, points ofmaximum displacement along end effector 104 may be in increments ofabout 0.5 to 1 inch, preferably 0.8 inches. As an example for PLLA, asan example at a frequency of 20 khz, points of maximum displacementalong end effector 104 may be in increments of about 1 to 2 inches,preferably 1.3 to 1.4 inches. As an example for PLLA, as an example at afrequency of 40 khz, points of maximum displacement along end effector104 may be in increments of about 0.5 to 1 inch, preferably 0.7 inches.

To optimize bonding and/or reduce the stress applied, the desired pointof bonding on fastener 170 should be at or near a point of maximumdisplacement. For example, the desired point of bonding on fastener 170may be along half its length or at its tip (see 218A of FIG. 48). If thedesired point of bonding is at a point of minimal or zero displacement(see 218B of FIG. 49), bonding may be difficult. To facilitate bonding,it may be preferable to increase power or amplitude of the signal,thereby increasing energy applied to fastener 170.

Referring to FIGS. 52-53, fastener 170T may be used with sleeve 171T,potentially to contain and/or release therapeutic substances into abody. Fastener 170T may engage with sleeve 171T by mechanical interlock,thread, or vibratory energy bond. End effector 104 may engage withfastener 170T for vibratory energy bonding. Any fastener 170 disclosedherein may have energy director 222 to facilitate bonding by directingenergy to the desired location of bonding.

Referring to FIGS. 54-55, fastener 170U may have energy director 224.Energy director 224 may facilitate bonding with implant 162, especiallyif a portion or the entirety of implant 162 includes a porous material.For example, implant 162 may include a porous metal. End effector 104may engage with fastener 170U for vibratory energy bonding.

Referring to FIG. 56, fastener 170F may be embedded into a bondablematerial with its leading end and stabilize a support 168 (i.e. plate)with its trailing end. End effector 104 may engage with fastener 170F,preferably near the trailing end, for vibratory energy bonding. Fastener170F may include any material disclosed herein, but preferably titaniumor titanium with at least a portion coated with PEEK or PLLA.

Referring to FIGS. 57-58, fastener 170W may be used with, preferablydisposed within, expanding anchor 226. End effector 104 may engage withfastener 170W, preferably near the trailing end, for vibratory energybonding. A hole in tissue and/or bondable material may be formed ordrilled into body tissue 160 prior to or during the implantation offastener 170W and expanding anchor 226. Fastener 170W and expandinganchor 226 may pass into body tissue 160, for example in theconfiguration shown in FIG. 57. Fastener 170W may be retracted intoexpanding anchor 226, preferably after being positioned in body tissue160. Expanding anchor 226 may expand outwards (shown in FIG. 58),thereby engaging and/or exerting a radially outward force on body tissue160. Preferably after fastener 170W and expanding anchor 226 are in anexpanded condition, vibratory energy may be applied to fastener 170W,preferably near the trailing end, to bond fastener 170W and expandinganchor 226 together. In another embodiment, fastener 170W and/orexpanding anchor 226 may be configured to bond into a bondable material.After fastener 170W and expanding anchor 226 have been stabilized in theexpanded configuration, the excess length of the trailing end offastener 170W may be removed to be substantially flush with the trailingend of expanding anchor 226.

Referring to FIG. 59, fastener 170 may be used to increase interferencebetween body tissue 160 and implant 198. Fastener 170 may be aninterference screw and/or used in conjunction with interference implant228 to position and/or stabilize implant 198. Fastener 170 may passthrough all or a portion of implant 198. In additional embodiments,fastener 170 may stabilize body tissue 160 (i.e. ACL graft) against theside of a hole in body tissue 160 (i.e. bone) (not shown), stabilizebody tissue 160 (i.e. soft tissue) to another body tissue 160 (i.e.bone), or stabilize interference implant 228 (or tissue graft 202) tobody tissue 160 (i.e. bone) and/or implant 198 (FIG. 59). In anotherembodiment, fastener 170 may be part or entirely made of a biodegradableand/or bondable material. In an embodiment, fastener 170 may have a snapthat would overlay part of implant 198 for interference. In anotherembodiment, implant 198 may include porous surface 230 (FIG. 59) or acoating of bondable material. In another example, implant 198 may bebonded with vibratory energy, hydrophilic, and/or mechanicallyexpandable against body tissue 160 (i.e. bone), which may allow theimplant to sequentially expand and provide interference against bodytissue 160 (i.e. bone) or another implant.

In an embodiment related to hip (or shoulder) resurfacing, implant 198may be an acetabular component or cup (or glenoid component), which iscommonly stabilized using screws through its center. To replace the useof these screws or to provide additional stabilization, implant 198 maybe stabilized by positioning fastener 170 between implant 198 and bodytissue 160 (i.e. acetabulum or glenoid), which may urge implant 198 tothe desired position and/or enhance interference with body tissue 160.In an embodiment, implant 198 may be free of holes, as fastener 170 mayprovide the majority of interference.

There are many different features to the present invention and itscontemplated that these features may be used together or separately.Thus, the invention should not be limited to any particular combinationof features or to a particular application of the invention. Further, itshould be understood that variations and modifications within the spiritand scope of the invention may occur to those skilled in the art towhich the invention pertains. Accordingly, all expedient modificationsreadily attainable by one versed in the art from the disclosure setforth herein that are within the scope and spirit of the presentinvention are to be included as further embodiments of the presentinvention.

1. A method of utilizing a bondable material to position a fasteningimplant in a body, said method comprising the steps of: engaging an endeffector and at least a trailing end of the fastening implant; passingat least a portion of the end effector and the fastening implant intothe body; positioning at least a leading end of the fastening implantadjacent the bondable material; applying vibratory energy to at leastthe trailing end, thereby transmitting vibratory energy to the leadingend to heat at least a portion of the bondable material in contact withthe leading end and embed at least a portion of the leading end into thebondable material; disengaging the end effector from the trailing end,and enclosing the fastening implant in the body.
 2. The method of claim1 wherein the bondable material is polymethyl methacrylate.
 3. Themethod of claim 1 wherein at least a portion of the fastening implant isbonded into the bondable material.
 4. The method of claim 1 wherein thebondable material is substantially hard before application of energy andat least a portion of the bondable material softens during theapplication of vibratory energy.
 5. The method of claim 1 wherein atleast a portion of the bondable material flows into the fasteningimplant to secure the at least a portion of the fastening implant to thebondable material.
 6. The method of claim 1 wherein disengaging includesrotationally disengaging the end effector from the fastening implant. 7.The method of claim 1 wherein the fastening implant includes at least aportion of titanium.
 8. The method of claim 1 wherein the fasteningimplant includes at least a portion of at least one of PEEK and PLLA. 9.The method of claim 1 wherein the fastening implant includes at least aportion of titanium and at least a portion of a polymer.
 10. The methodof claim 1 wherein vibratory energy includes ultrasonic energy.
 11. Themethod of claim 1 wherein the fastening implant is positioned adjacent aspine of the body to stabilize at least a portion of the spine.
 12. Themethod of claim 1 wherein the fastening implant stabilizes a bone of abody by embedding in a previously hardened bondable material adjacent tothe bone.
 13. The method of claim 1 wherein the end effector isdisengaged from the fastening implant when the bondable material coolsand the fastening implant is left in the body.
 14. The method of claim 1wherein the fastening implant is positioned relative to a supportingimplant, the supporting implant including a plate.
 15. A method ofutilizing a bondable material adjacent a tissue in a body, said methodcomprising the steps of: engaging an embedding implant and an endeffector; passing the embedding implant and at least a portion of theend effector into the body; positioning the embedding implant adjacentthe bondable material; applying vibratory energy to the embeddingimplant to embed the embedding implant into at least a portion of thebondable material; and engaging a fastening implant with the embeddingimplant to secure the tissue, and enclosing the fastening implant andembedding implant in the body.
 16. The method of claim 15 wherein theembedding implant is bonded to the bondable material.
 17. The method ofclaim 15 wherein the bondable material is polymethyl methacrylate. 18.The method of claim 15 wherein energy includes ultrasonic energy. 19.The method of claim 15 wherein the bondable material has previouslypolymerized before positioning the embedding implant.
 20. The method ofclaim 15 wherein bondable material flows around the fastening implantduring application of vibratory energy.
 21. The method of claim 15wherein the bondable material flows into the fastening implant duringapplication of vibrator energy.
 22. A method of utilizing a bondablematerial adjacent a tissue in a body, said method comprising the stepsof: engaging an embedding implant and an end effector; passing theembedding implant and at least a portion of the end effector into thebody; positioning the embedding implant adjacent the bondable material;applying vibratory energy to the embedding implant to embed theembedding implant into at least a portion of the bondable material;positioning a supporting implant adjacent the tissue; engaging afastening implant and the embedding implant to secure the supportingimplant adjacent the tissue; and enclosing the fastening implant andembedding implant in the body.
 23. The method of claim 22 wherein theembedding implant is bonded to the bondable material.
 24. The method ofclaim 22 wherein the bondable material is polymethyl methacrylate. 25.The method of claim 22 wherein vibratory energy includes ultrasonicenergy.
 26. The method of claim 22 wherein the bondable material haspreviously polymerized before positioning the embedding implant.
 27. Themethod of claim 22 wherein bondable material flows around the fasteningimplant during application of vibratory energy.
 28. The method of claim22 wherein the bondable material flows into the fastening implant duringapplication of vibrator energy.
 29. The method of claim 22 wherein thesupporting implant includes a plate.
 30. The method of claim 22 whereinthe tissue includes a bone of the body.
 31. The method of claim 22wherein the tissue includes at least a portion of a spine of the body.32. A method to facilitate bonding of an implant and bondable materialin a body, said method comprising the steps of: passing the implant andat least a portion of an end effector into the body; positioning atleast a portion the implant in bondable material, the bondable materialbeing malleable; engaging the end effector and implant; applyingvibratory energy to the implant to increase the solidification of thebondable material; and enclosing the implant in the body.
 33. The methodof claim 32 wherein the bondable material is substantially solidifiedwhile the end effector and implant are engaged.
 34. The method of claim32 wherein the bondable material is polymethyl methacrylate.
 35. Themethod of claim 32 wherein vibratory energy includes ultrasonic energy.36. The method of claim 32 which further includes the step ofdisengaging the end effector after the polymerization of the bondablematerial has been increased.
 37. The method of claim 32 wherein bondablematerial flows around the implant during the application of energy. 38.The method of claim 32 wherein the bondable material flows into theimplant during the application of energy.
 39. The method of claim 32wherein the implant includes an intramedullary rod.